Botulinum Toxin for Stomach Cancer Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01822210|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms||Drug: Botox||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Botulinum Toxin (BOTOX) for Stomach Cancer Treatment|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Injection of Botox in the tumor and surrounding stomach wall.
injection by gastroscopy (100 Allergen units)
Other Name: Botulinum toxin
- Change of tumor volume in the stomach. [ Time Frame: Baseline and 8 weeks ]Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
- Change of tumor volume in the stomach. [ Time Frame: 8 weeks and 20 weeks ]Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
- Toxicity [ Time Frame: 2 weeks ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Toxicity [ Time Frame: 8 weeks ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- performance status [ Time Frame: 2 weeks ]ECOG scale
- performance status [ Time Frame: 8 weeks ]ECOG scale
- performance status [ Time Frame: 20 weeks ]ECOG scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822210
|Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital|
|Principal Investigator:||Jon Erik Grønbech, MD. PhD.||St. Olavs Hospital|